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Singing for People With Aphasia (SPA)

2018年10月10日 更新者：University of Exeter

Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing

To undertake a pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of SPA (which would assess the clinical and cost effectiveness of SPA for people with aphasia)

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Beyond language function, people with aphasia (PWA) report a range of health problems which negatively affect wellbeing, including reduced confidence and social isolation. These psychosocial outcomes of aphasia are not sufficiently met by healthcare services: improvements in language function do not appear to lead to improvements in wellbeing. National clinical guidelines for stroke reflect this observation and highlight the need for community integration and participation of people with aphasia. This research is about singing groups for people with aphasia (SPA) and is intended to address this need by focusing on the wellbeing and social participation needs of people with aphasia after stroke.

The Investigators engagement activities and early development project provided strong impetus for the proposed study: people with aphasia repeatedly told the investigators that singing in groups may help the participants to reconnect with society, and that this will improve wellbeing.

The investigators have planned a pilot study that will allow an assessment of the extent to which the study processes and the singing groups themselves are feasible to run and are acceptable to participants. The information from this work will help the investigators to decide whether to conduct a larger randomised controlled trial (RCT) which would be a fair test of whether SPA can improve the lives of individuals with post stroke aphasia.

研究の種類

介入

入学 (実際)

41

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
      • Exeter、イギリス、EX1 2LU
        • University of Exeter

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Diagnosis of aphasia after stroke
  • Willingness to be randomised to either control or SPA (and able to attend the singing venue)
  • Conversational English speaker pre-morbidly
  • Capacity to consent (assessed by recruiting team using standard tools)

Exclusion Criteria:

  • <18 years old
  • Currently engaged in a speech or language therapy programme
  • Intention to relocate outside the geographical region during the study
  • Current participation in another study involving a lifestyle intervention
  • Currently attending a singing/music group

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Resource pack
Aphasia resource pack
行動：Resource pack
Resource pack with information on living with aphasia and local community activities.
実験的：Singing group + resource pack
Singing group + Aphasia resource pack
行動：Singing group + resource pack
SPA is a community-based, 10 weekly singing group. Each SPA session comprises 30 minutes of settling in/wrap-up and departure, and 60 minutes of group singing. Sessions will be led by a community music leader, co-facilitated by a person with aphasia, and involve the group singing from a songbook. Musical accompaniment will be provided by the facilitator(s). Small percussion instruments will be available for participants, enabling involvement of those with limited singing ability. Intervention content integrates the Information-Motivation-Behavioural (IMB) skills model of health behaviour change to support individuals in developing the social skills and confidence needed to improve psychosocial outcomes. Participants will also receive the resource pack.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
ICEpop CAPability measure for Adults (ICECAP-A)
時間枠：Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
A 5-item measure of capability for the general adult (18+) population for use in economic evaluation. It focuses on wellbeing and comprises five attributes: Attachment, Stability, Achievement, Enjoyment, Autonomy.
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
Stroke and Aphasia Quality of Life Scale (SAQOL - 39)
時間枠：Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
A 39-item health-related quality of life measure with 4 subdomains: physical, psychosocial, communication, and energy.
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
EQ-5D-5L (health-related quality of life states consisting of five dimensions)
時間枠：Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
A 5-item measure of health-related quality of life (plus EQ-VAS visual analogue scale), that can be used for cost utility analysis.
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
modified Reintegration to Normal Living (mRNL)
時間枠：Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
An 11-item measure that captures social participation (e.g. recreation, movement in the community, and interaction in family or other relationships).
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Communication Outcome After STroke (COAST)
時間枠：Measures change from baseline to 6 months post intervention
A 20-item measure of communication effectiveness for people with any type of communication problem following stroke
Measures change from baseline to 6 months post intervention
Very Short Version of the Minnesota Aphasia test
時間枠：Measures change from baseline to 6 months post intervention
A diagnostic tool to identify aphasia type. Comprised of 4 activities: Identifying names, oral reading words, naming pictures, and written spelling. Audio-recorded to allow for diagnosis of aphasia severity.
Measures change from baseline to 6 months post intervention
Service Receipt Inventory
時間枠：Measures change from baseline to 6 months post intervention
Record of types and amount of use of health and social care resources including clinical contacts, formal and informal social care. Completed by Assessor drawing on participant and family accounts.
Measures change from baseline to 6 months post intervention
Care related Quality of Life (CarerQoL-7D)48
時間枠：Measures change from baseline to 6 months post intervention
For completion by carers. A 7-item measures of the impact of providing informal care on carers. Utility tariffs to calculate a weighted sum score of the CarerQol-7D are also available.
Measures change from baseline to 6 months post intervention
Adverse incidents
時間枠：Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
Adverse events used to gauge the safety of the intervention
Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.

その他の成果指標

結果測定
メジャーの説明
時間枠
Recruitment
時間枠：From the start of participant identification through to participant randomisation, over a period of 8 months
An assessment of the recruitment to the trial
From the start of participant identification through to participant randomisation, over a period of 8 months
Retention
時間枠：From Randomisation through study completion, an average of 36 weeks
An assessment of the retention rates in the trial
From Randomisation through study completion, an average of 36 weeks
Qualitative Interviews
時間枠：Interviews to be conducted 3 months post-intervention
15 Qualitative interviews across the intervention and control groups to discuss individuals' experiences of the trial processes and the intervention. Participants will report on the acceptability of trial and intervention activities
Interviews to be conducted 3 months post-intervention
Intervention fidelity (intervention group only): Singing group attendance
時間枠：During the intervention, up to 10 weeks
A register of attendance at the singing group
During the intervention, up to 10 weeks
Intervention fidelity (intervention group only): Session adherence
時間枠：During the intervention, up to 10 weeks
Group facilitators will record which aspects of the intervention manual have been followed during the group session
During the intervention, up to 10 weeks
Intervention fidelity (intervention group only): Observations
時間枠：During the intervention, up to 10 weeks
The research team will observe and record the extent to which the group facilitators are following the key elements of the intervention manual and the participants are adhering to facilitator instructions
During the intervention, up to 10 weeks
Intervention fidelity (intervention group only): Video recordings
時間枠：During the intervention, up to 10 weeks
The research team will video-record a selection of singing group sessions to assess facilitator and participant adherence
During the intervention, up to 10 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Exeter

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年6月1日

一次修了 (実際)

2018年9月27日

研究の完了 (実際)

2018年9月27日

試験登録日

最初に提出

2017年2月28日

QC基準を満たした最初の提出物

2017年3月6日

最初の投稿 (実際)

2017年3月10日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月11日

QC基準を満たした最後の更新が送信されました

2018年10月10日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 1617\014\140293

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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条件

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スポンサー/協力者

場所

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